MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT AXSOS 3 TI NON-LOCKING, SHORT, 3.2 X 216MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	705032
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
It was reported via medwatch (b)(4) that during open reduction internal fixation (orif) hip, tip of drill was broken during surgery, it was embedded in the bone.The surgeon decided to keep the broken tip in situ.No harm known to patient.It as further clarified in a surgeon note that: ""patient had relatively good bone quality and all screws had excellent bite".At least 6 cortical screws +lag screw, then drilled and placed multiple distal femoral locking screws after lagging in, the remaining screws were placed in locking mode.A total of 19 screws implanted.To not compromise the stability of the construction and revision femoral stem, drill bit was retained in the best interest of the patient.Site closed with stratafix, skin closed with staples, sterile dressing applied.".
Additional Manufacturer Narrative
The reported condition could be confirmed as the drill bit is broken as reported.The device inspection revealed the following: the front part of the drill bit is broken off at the cross over from the cutting flutes to the shaft.The fracture face has the typical view of a brittle overload fracture, at the fracture initiation zone are deformations visible, which indicates a metallic contact.In general it the drill bit in a very used condition, the remaining cutting edges are blunt and there are strong stress marks at the shaft visible.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to be user related.The appearance of the fracture zone indicates that a excessive metallic contact, for example with an already inserted screw did lead to a mechanical overload and finally the breakage of the device.If any further information is provided, the investigation report will be updated.
Event or Problem Description
It was reported via medwatch (b)(4) that during open reduction internal fixation (orif) hip, tip of drill was broken during surgery, it was embedded in the bone.The surgeon decided to keep the broken tip in situ.No harm known to patient.It as further clarified in a surgeon note that: ""patient had relatively good bone quality and all screws had excellent bite".At least 6 cortical screws +lag screw, then drilled and placed multiple distal femoral locking screws after lagging in, the remaining screws were placed in locking mode.A total of 19 screws implanted.To not compromise the stability of the construction and revision femoral stem, drill bit was retained in the best interest of the patient.Site closed with stratafix, skin closed with staples, sterile dressing applied.".

• Brand Name: DRILL BIT AXSOS 3 TI NON-LOCKING, SHORT, 3.2 X 216MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11966798
• Report Number: 0008031020-2021-00259
• Device Sequence Number: 4544045
• Product Code: HWE
• UDI-Device Identifier: 07613327083446
• UDI-Public: 07613327083446
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 705032
• Device Catalogue Number: 705032
• Device Lot Number: 14752G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR